Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib
NCT ID: NCT06120140
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
300 participants
INTERVENTIONAL
2024-02-16
2032-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A: Enhanced Dermatologic Management
Participants will receive enhanced dermatologic management to reduce toxicities in skin and nail with doxycycline tablet or minocycline capsule, clindamycin topical lotion, chlorhexidine topical solution, and noncomedogenic skin moisturizer during background anticancer treatment of advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) with amivantamab intravenously (Dose 1 for body weight \[BW\] less than 80 kilograms \[kg\] and Dose 2 for BW greater than or equal to \[\>=\] 80 kg as IV infusion \[Arm A\]) until documented disease progression using Response Evaluation Criteria in Solid Tumors version 1.1).
Lazertinib
Lazertinib tablet will be administered orally.
Doxycycline
Doxycycline tablet will be administered orally.
Minocycline
Minocycline capsule will be administered orally.
Clindamycin
Clindamycin lotion will be used as topical application on the scalp.
Chlorhexidine
Chlorhexidine solution will be used as topical application on hands and feet.
Noncomedogenic skin moisturizer
Noncomedogenic skin moisturizer will be used as topical application.
Amivantamab IV
Amivantamab will be administered.
Arm B: Standard-of-Care Dermatologic Management
Participants will receive standard care for dermatologic management according to local practice to reduce dermatologic toxicities in skin and nail during background anticancer treatment of advanced or metastatic EGFR-mutated NSCLC with amivantamab administered as IV infusion plus lazertinib, dose and dosing schedule as same as experimental arm.
Lazertinib
Lazertinib tablet will be administered orally.
Chlorhexidine
Chlorhexidine solution will be used as topical application on hands and feet.
Noncomedogenic skin moisturizer
Noncomedogenic skin moisturizer will be used as topical application.
Amivantamab IV
Amivantamab will be administered.
Sub-study: Cohort A: Ruxolitinib
Participants enrolled in Arms A and B of the main study who experience new-onset or persistent specific DAEIs (Grade greater than or equal to \[\>=\] 2, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI-CTCAE\] v5.0) will be enrolled and receive reactive treatment with ruxolitinib in the sub-study. Participants in the sub-study will continue to receive amivantamab and lazertinib.
Lazertinib
Lazertinib tablet will be administered orally.
Doxycycline
Doxycycline tablet will be administered orally.
Minocycline
Minocycline capsule will be administered orally.
Clindamycin
Clindamycin lotion will be used as topical application on the scalp.
Chlorhexidine
Chlorhexidine solution will be used as topical application on hands and feet.
Noncomedogenic skin moisturizer
Noncomedogenic skin moisturizer will be used as topical application.
Ruxolitinib
Ruxolitinib will be used to the affected skin area.
Amivantamab IV
Amivantamab will be administered.
Sub-study: Cohort B: Tacrolimus
Participants enrolled in Arms A and B of the main study who experience new-onset or persistent specific DAEIs (Grade \>= 2, as defined by NCI-CTCAE v5.0) will be enrolled and receive reactive treatment with tacrolimus in the sub-study. Participants in the sub-study will continue to receive amivantamab and lazertinib.
Lazertinib
Lazertinib tablet will be administered orally.
Doxycycline
Doxycycline tablet will be administered orally.
Minocycline
Minocycline capsule will be administered orally.
Clindamycin
Clindamycin lotion will be used as topical application on the scalp.
Chlorhexidine
Chlorhexidine solution will be used as topical application on hands and feet.
Noncomedogenic skin moisturizer
Noncomedogenic skin moisturizer will be used as topical application.
Tacrolimus
Tacrolimus will be used as topical application to the affected skin area.
Amivantamab IV
Amivantamab will be administered.
Amivantamab Subcutaneous (SC) Expansion Cohort: Modified Enhanced Dermatologic Management
Participants will receive modified enhanced dermatologic management with oral doxycycline or minocycline, zinc gluconate and noncomedogenic skin moisturizer during background anticancer treatment of advanced or metastatic EGFR mutated NSCLC with amivantamab SC and lazertinib. If a participant develops a dermatologic adverse event of interest (DAEI) they will receive early intervention as follows: for facial (ruxolitinib), for scalp (oral propranolol and clobetasol), for paronychia (chlorhexidine in addition to timolol) until documented disease progression using Response Evaluation Criteria in Solid Tumors version 1.1).
Amivantamab SC
Amivantamab will be administered as SC injection.
Lazertinib
Lazertinib tablet will be administered orally.
Doxycycline
Doxycycline tablet will be administered orally.
Minocycline
Minocycline capsule will be administered orally.
Chlorhexidine
Chlorhexidine solution will be used as topical application on hands and feet.
Noncomedogenic skin moisturizer
Noncomedogenic skin moisturizer will be used as topical application.
Ruxolitinib
Ruxolitinib will be used to the affected skin area.
Zinc gluconate
Zinc gluconate tablet will be administered.
Propranolol
Propranolol tablet will be administered.
Timolol
Timolol will be used to the affected skin area.
Clobetasol
Clobetasol shampoo will be used on the scalp.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Amivantamab SC
Amivantamab will be administered as SC injection.
Lazertinib
Lazertinib tablet will be administered orally.
Doxycycline
Doxycycline tablet will be administered orally.
Minocycline
Minocycline capsule will be administered orally.
Clindamycin
Clindamycin lotion will be used as topical application on the scalp.
Chlorhexidine
Chlorhexidine solution will be used as topical application on hands and feet.
Noncomedogenic skin moisturizer
Noncomedogenic skin moisturizer will be used as topical application.
Ruxolitinib
Ruxolitinib will be used to the affected skin area.
Tacrolimus
Tacrolimus will be used as topical application to the affected skin area.
Zinc gluconate
Zinc gluconate tablet will be administered.
Propranolol
Propranolol tablet will be administered.
Timolol
Timolol will be used to the affected skin area.
Clobetasol
Clobetasol shampoo will be used on the scalp.
Amivantamab IV
Amivantamab will be administered.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Have a tumor that harbors an epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution, as detected by an Food and Drug Administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA)-certified laboratory (sites in the United States) or an accredited local laboratory (sites outside of the United States) in accordance with site standard-of-care
* A participant with asymptomatic or previously treated and stable brain metastases may participate in this study. Participants with a history of symptomatic brain metastases must have had all lesions treated as clinically indicated (that is, no current indication for further definitive local therapy). Any definitive local therapy to brain metastases must have been completed at least 14 days prior to randomization, and the participant can be receiving no greater than 10 milligram (mg) prednisone or equivalent daily for the treatment of intracranial disease
* Can have prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints, safety, or the efficacy of the study treatment(s). For the amivantamab SC expansion cohort: Due to the increased risk of skin cancer with ruxolitinib, participants with any prior or concurrent skin malignancies will be excluded
* Sub-study: Participants must have new-onset or persistent (defined as non-responsive to standard of care \[SoC\]) Grade \>=2 specific DAEIs of the scalp, face, or body, as defined by NCI-CTCAE Grading v5.0 for DAEIs (excluding paronychia)
Exclusion Criteria
* Medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
* Known allergy, hypersensitivity, or intolerance to the excipients of amivantamab, lazertinib, or to tetracyclines, doxycycline, minocycline, timolol\*, ruxolitinib\*, zinc\*, corticosteroids\* or their excipients or to any component of the enhanced dermatologic management (\*for the amivantamab SC expansion cohort)
* Participant has received any prior systemic treatment at any time for locally advanced stage III B/C or metastatic stage IV disease (adjuvant or neoadjuvant therapy for stage I, II or IIIA disease is allowed if last dose administered more than 12 months prior to the development of locally advanced or metastatic disease)
* Participant has an active or past medical history of leptomeningeal disease
* Sub-study: Participants who have received prior treatment for epidermal growth factor receptor (EGFR)-induced DAEIs with JAK inhibitors (for Cohort A) or calcineurin inhibitors (for Cohort B)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Janssen Research & Development, LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ironwood Cancer and Research Center
Chandler, Arizona, United States
City of Hope
Duarte, California, United States
Providence Fullerton
Fullerton, California, United States
Los Angeles Cancer Network
Glendale, California, United States
City of Hope Seacliff
Huntington Beach, California, United States
City of Hope Orange County Lennar Foundation Cancer Center
Irvine, California, United States
City of Hope Long Beach Elm
Long Beach, California, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
Keck Hospital of USC
Los Angeles, California, United States
USC Norris Oncology Hematology Newport Beach
Newport Beach, California, United States
Kaiser Permanente Oakland Medical Center
Oakland, California, United States
Kaiser Permanente Roseville Medical Center
Roseville, California, United States
Kaiser Permanente San Francisco Medical Center
San Francisco, California, United States
Kaiser Permanente Santa Clara Medical Center
Santa Clara, California, United States
City of Hope South Pasadena
South Pasadena, California, United States
Kaiser Permanente Northern California
Vallejo, California, United States
Kaiser Permanente Walnut Creek Medical Center
Walnut Creek, California, United States
University Cancer & Blood Center
Athens, Georgia, United States
Hope and Healing Care
Hinsdale, Illinois, United States
Oncology Hematology Associates
Springfield, Missouri, United States
Renown Health Medical Oncology
Reno, Nevada, United States
Hunterdon Hematology Oncology
Flemington, New Jersey, United States
Clinical Research Alliance Inc
Westbury, New York, United States
Regional Medical Oncology Center
Wilson, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Valley Medical Center
Renton, Washington, United States
Gundersen Health System
West Salem, Wisconsin, United States
Hospital Italiano de Buenos Aires
Buenos Aires, , Argentina
IADT Instituto Argentino de Diagnostico y Tratamiento
CABA, , Argentina
Centro Medico Austral
Capital Federal, , Argentina
Hospital Italiano de La Plata
La Plata, , Argentina
Hospital Privado de la Comunidad
Mar del Plata, , Argentina
CTO Centro De Tratamento Oncologico LTDA
Belém, , Brazil
Santa Casa de Misericordia de Belo Horizonte
Belo Horizonte, , Brazil
Liga Paranaense de Combate ao Cancer
Curitiba, , Brazil
Fundacao Doutor Amaral Carvalho
Jaú, , Brazil
Hospital Nossa Senhora da Conceicao S A
Porto Alegre, , Brazil
Nucleo de Oncologia da Bahia Oncoclinicas
Salvador, , Brazil
Hospital Ana Nery Santa Cruz do Sul
Santa Cruz do Sul, , Brazil
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
São Paulo, , Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, , Brazil
Servicos de Tratamento ao Cancer de Taubate LTDA - Instituto do Cancer Brasil Unidade Taubate
Taubaté, , Brazil
Associacao Feminina de Educacao e Combate ao Cancer Hospital Santa Rita de Cassia
Vitória, , Brazil
Changzhou No 2 Peoples Hospital
Changzhou, , China
West China Hospital
Chengdoucun, , China
Sichuan Cancer Hospital
Chengdu, , China
The First Affiliated Hospital Sun Yat sen University
Guangzhou, , China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, , China
Harbin medical university cancer hospital
Harbin, , China
Huizhou Municipal Central Hospital
Huizhou, , China
Zhongda Hospital Southeast University
Nanjing, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, , China
Henan Cancer Hospital
Zhengzhou, , China
Hopital Nord
Marseille, , France
Hopital PASTEUR
Nice, , France
Institut Curie
Paris, , France
Universitaetsklinikum der RWTH Aachen
Aachen, , Germany
Kliniken Essen-Mitte
Essen, , Germany
Universitaetsklinikum Giessen und Marburg GmbH
Giessen, , Germany
Thoraxklinik am Universitatsklinikum Heidelberg
Heidelberg, , Germany
Klinikum Kassel GmbH
Kassel, , Germany
Universitaetsklinikum Schleswig Holstein Campus Kiel
Kiel, , Germany
Hospital Pulau Pinang
George Town, , Malaysia
University Malaya Medical Centre
Kuala Lumpur, , Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, , Malaysia
Hospital Umum Sarawak
Kuching, , Malaysia
Chungbuk National University Hospital
Cheongju-si, , South Korea
Gachon University Gil Hospital
Incheon, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Hosp Univ A Coruna
A Coruña, , Spain
Hosp. Gral. Univ. de Alicante
Alicante, , Spain
Hosp. Univ. Quiron Dexeus
Barcelona, , Spain
Hosp Univ Vall D Hebron
Barcelona, , Spain
Hosp. Univ. de Jaen
Jaén, , Spain
Hosp. Univ. Lucus Augusti
Lugo, , Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, , Spain
Hosp Regional Univ de Malaga
Málaga, , Spain
Hosp. Ntra. Sra. de Valme
Seville, , Spain
Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan, , Taiwan
National Taiwan University Hospital Hsin Chu Branch
Taoyuan District, , Taiwan
Adana City Hospital
Adana, , Turkey (Türkiye)
Gulhane Training and Research Hospital
Ankara, , Turkey (Türkiye)
Gazi University Hospital
Ankara, , Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, , Turkey (Türkiye)
Bakirkoy Training and Research Hospital
Istanbul, , Turkey (Türkiye)
I A U VM Medical Park Florya Hastanesi
Istanbul, , Turkey (Türkiye)
Ege University Medical Faculty
Izmir, , Turkey (Türkiye)
Ondokuz Mayis University
Samsun, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
61186372NSC2007
Identifier Type: OTHER
Identifier Source: secondary_id
2023-505863-35-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
61186372NSC2007
Identifier Type: -
Identifier Source: org_study_id